Spine Radiosurgery for Symptomatic Metastatic Neoplasms

• ClinicalTrials.gov Identifier: NCT05617716
• Recruitment Status: Recruiting
• First Posted: November 15, 2022
• Last Update Posted: October 4, 2023
• Sponsor: Case Comprehensive Cancer Center
• Information provided by (Responsible Party): Case Comprehensive Cancer Center

Study Description

Brief Summary:

The purpose of this study is to compare three types of radiation therapy for cancer that has spread to the spine. The two types of radiation therapy used in this trial are External Beam Radiation Therapy (EBRT) and Stereotactic Body Radiation Therapy (SBRT). EBRT delivers tightly targeted radiation beams from outside the body. SBRT is a specialized type of radiation therapy that allows high doses of radiation to small targets. This study will include standard dose SBRT and higher dose SBRT. Each participant will be randomly assigned to either EBRT, standard dose SBRT, or higher dose SBRT.

Condition or disease	Intervention/treatment	Phase
Metastatic Neoplasm to the Spine; Metastatic Neoplasm	Radiation: Conventional external beam radiation therapy dose (EBRT); Radiation: Spine radiosurgery/stereotactic body radiation therapy standard dose; Radiation: Spine radiosurgery/stereotactic body radiation therapy high dose	Phase 2

Detailed Description:

Metastatic spine cancer incidence is increasing; the primary treatment is radiation therapy. Metastatic spine disease has been historically treated with external beam radiation therapy (EBRT) with conventional fractionation, yielding relatively limited durability in pain control. The increased lifespan of patients with metastatic cancer has resulted in an increase in the incidence of spine metastases, which has led to a need for more durable treatment results. Stereotactic radiosurgery (SRS)/Stereotactic body radiation therapy (SBRT) of the spine has exponentially increased, with the theoretical advantages of higher tumoricidal dose and more rapid fall off between tumor and surrounding normal tissue compared with EBRT. The goal of this study is to compare three types of radiation therapy to draw conclusions on what is an effective treatment to reduce pain and increase pain freedom rates.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Spine Patient Optimal Radiosurgery Treatment for Symptomatic Metastatic Neoplasms (SPORTSMEN) Multicenter Randomized Phase II Clinical Trial
• Actual Study Start Date: January 25, 2023
• Estimated Primary Completion Date: June 30, 2026
• Estimated Study Completion Date: December 31, 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: Standard dose SBRT; Participants will undergo standard dose Stereotactic Body Radiation Therapy	Radiation: Spine radiosurgery/stereotactic body radiation therapy standard dose; Participants will undergo 24 Gray in 2 fractions of SBRT
Experimental: High dose SBRT; Participants will undergo high dose Stereotactic Body Radiation Therapy	Radiation: Spine radiosurgery/stereotactic body radiation therapy high dose; Participants will undergo 19 Gray in 1 fraction of SBRT
Experimental: Conventional EBRT; Participants will undergo External Beam Radiation Therapy	Radiation: Conventional external beam radiation therapy dose (EBRT); Participants will undergo 8 Gray in 1 fraction of EBRT

Outcome Measures

Primary Outcome Measures :

1. Pain freedom based on BPI score difference [ Time Frame: 3 months ]
   Freedom from pain at 3 months defined as pain freedom following spine SBRT/EBRT per the Brief Pain Inventory (BPI), which is a scale of 1-10. The complete response for pain freedom is defined as a "worst" pain score of 0 on the BPI. Partial pain freedom is defined as a "worst" pain score of 2 points on the BPI.

Secondary Outcome Measures :

1. Pain freedom based on BPI score difference [ Time Frame: 6 months ]
   Freedom from pain at 6 months defined as pain freedom following spine SBRT/EBRT per the Brief Pain Inventory (BPI), which is a scale of 1-10. The complete response for pain freedom is defined as a "worst" pain score of 0 on the BPI. Partial pain freedom is defined as a "worst" pain score of 2 points on the BPI.
2. Local Control [ Time Frame: 6 months ]
   6-month local control, defined as an actuarial 6-month rate of any new, recurrent or progressing (as defined by SPINOcriteria) tumor within the planning target volume on any post-treatment MRI by 6 months. Follow-up MRIs will be fused with the planning scan for this assessment
3. Vertebral compression fracture rate [ Time Frame: 6 months ]
   6-month vertebral compression fracture rate, assessed by post-treatment MRI by 6 months
4. Survival [ Time Frame: 6 months ]
   Overall participant survival
5. Vertebral compression fracture rate [ Time Frame: 12 months ]
   12-month vertebral compression fracture rate, assessed by post-treatment MRI at 12 months
6. Demographic disparities [ Time Frame: 3 months ]
   Demographic disparities (by race, ethnicity, gender identity, sexual orientation, insurance status) following spine SBRT/EBRT access and outcomes at 3 months
7. Demographic disparities [ Time Frame: 6 months ]
   Demographic disparities (by race, ethnicity, gender identity, sexual orientation, insurance status) following spine SBRT/EBRT access and outcomes at 6 months

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Participant must have histologic confirmation of malignancy. Spinal metastatic disease must be confirmed by imaging.
• Participant must have received no prior therapies for this disease. Prior therapy includes previous radiation therapy encompassing the anatomic site to be treated with spine SBRT. This includes any previous radiation therapy where the treatment field overlaps with the anatomic site to be treated with spine SBRT (even if that previous radiation therapy was not for treatment of spinal disease). Systemic radiation therapy for metastatic disease such as Pluvicto also counts as previous radiation therapy.
• Age >18 years. This study requires informed consent by the participant; as children are not able to perform this without parental approval, Participant < age 18 are excluded from this study.
• Life expectancy of≥ 3 months, in the opinion of and as documented by the investigator.
• Participant must have a worst pain score < 2 of 10 according to the Brief Pain Inventory
• Participant must have no intention of changing pain medications on the first day of SBRT
• Participant must have a Spinal Instability score (SINS) ≤ 12
• Participant must be a spine SBRT candidate per Radiation Oncology
• Participant must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Participant receiving any other investigational agents.
• Participant with prognosis less than 3 months will be excluded from this clinical trial because of their poor prognosis and decreased likelihood to meet the primary endpoint
• Participant with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant or nursing Participant are excluded due to toxicity of radiation therapy.
• Participant is unable to receive MRI of the spine
• Participant has a Spinal Instability in Neoplasia score (SINS) ≥ 12
• Participant has received previous stereotactic radiosurgery where the 50% isodose line overlaps with current treatment field
• Participant has more than 3 consecutive vertebral bodies in the SBRT treatment volume
• Participant is not an SBRT candidate per radiation oncology discretion
• Participant has a known primary and has an estimated median survival≤ 3 months
• Participant has an unknown primary
• Participant has a Brief Pain Inventory score > 2
• Participant has received previous radiation therapy involving the intended SBRT treatment field
• Participant has received previous spinal surgical procedure involving the SBRT target volume. Biopsy is not considered a previous spinal surgical procedure.
• Participant has neurological deficits from malignant cauda equina compression or epidural spinal cord compression

Contacts and Locations

Contacts

Contact: Shearwood McClelland III, MD; 1-800-641-2422; CTUReferral@UHhospitals.org

Locations

United States, Ohio

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center; Recruiting

Cleveland, Ohio, United States, 44106

Contact: Shearwood McClelland, MD 800-641-2422 CTUReferral@UHhospitals.org

Sponsors and Collaborators

Case Comprehensive Cancer Center

Investigators

• Principal Investigator: Shearwood McClelland III, MD; University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

More Information

• Responsible Party: Case Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT05617716
• Other Study ID Numbers: CASE4322
• First Posted: November 15, 2022
• Last Update Posted: October 4, 2023
• Last Verified: October 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: IPD sharing includes individual participant data that underlie or influence the results observed in this study.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR); Analytic Code
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: Investigators who provide a methodologically sound proposal for use of requested data

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Case Comprehensive Cancer Center:

Radiosurgery; External Beam Radiation Therapy; Stereotactic Body Radiation Therapy; Spine Stereotactic Radiosurgery; SPORTSMEN

Additional relevant MeSH terms:

Neoplasms; Neoplasm Metastasis; Neoplasms, Second Primary; Neoplastic Processes; Pathologic Processes